Intraoperative IV Iron on Postoperative Red Blood Cell Recovery

Osteoarthritis, Hip Clinical Trial

Official title:

Intraoperative IV Iron on the Postoperative Recovery of Red Blood Cell in Hip Arthroplasty Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04035902
• Other study ID #: KUH 2019-05-008
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 2021
• Est. completion date: December 2021

Study information

• Verified date: August 2020
• Source: Konkuk University Medical Center
• Contact: Tae-Yop Kim, MD PhD
• Phone: 0220305445
• Email: taeyop[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the present study is to determine the impact of intraoperative IV-iron supplementation on postoperative recovery of RBC mass by retrospectively analyzing and comparing the changes of postoperative hematocrit values after the surgery in patients underwent elective uni-limb total knee arthroplasty surgery with or without IV-iron supplementation during surgery

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion criteria

• Patients with osteoarthritis in knee joint undergoing elective uni-limb total knee arthroplasty surgery

• Patients provided a written informed consent.

• Patients with s-ferritin < 300 mg/dl (male) or 200 mg/dl (female)

• Patients with preoperative serum hemoglobin concentration >10 g/dL

Exclusion criteria

• Patients with history of anaphylaxis, iron overload, active infection.

• Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Drug:
• Ferric carboxymaltose
Ferric carboxymaltose is administered during surgery
• control
Ferric carboxymaltose is not administered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative hematocrit (%)	hematocrit is evaluated on postoperative 7 days	7 days after surgery
Secondary	volume of post-operative bleeding (ml)	total volume of postoperative bleeding collected in the drainage container (hemovac)	7 day
Secondary	intraoperative blood transfusion (ml)	total volume of intraoperative blood transfusion	1 day
Secondary	post-operative blood transfusion (ml)	total amount of post-operative blood transfusion (ml)	7 days
Secondary	post-operative serum ferritin level (ng/ml)	post-operative serum ferritin level (ng/ml) is checked immediately after surgery	1 day